The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Sterile Powder Free Latex Surgeon Gloves With Protein Labeling Claim (50 Microgram Or Less).
| Device ID | K014230 |
| 510k Number | K014230 |
| Device Name: | STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) |
| Classification | Surgeon's Gloves |
| Applicant | SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-26 |
| Decision Date | 2002-03-13 |